If It Works, Replicate It: Generic COVID-19 Drugs

Nearly 3 dozen companies have been licensed to produce a cheaper version of a Pfizer oral COVID-19 treatment (Paxlovid) for lower-income countries (i.e. Generic COVID-19 drug). Of these companies, there are firms representing China, Israel, India and the USA. 

Charitable Initiative

These 3 dozen companies are working with the Medicines Patent Pool (MPP) to make use of Pfizer’s intellectual property to recreate generic Paxlovid. The MPP aims to assist global health by licensing needed medicines and pooling intellectual property to encourage generic manufacture and the development of new formulations. Already MPP has signed agreements with 13 patent holders for technologies applied to HIV, hepatitis C, tuberculosis, and COVID-19 testing.

“This will make an enormous difference for countries,” said Charles Gore, executive director of the Medicines Patent Pool. He said the availability of the Pfizer drug in some of the world’s poorest countries is especially critical. “They have been at the back of the queue for vaccines, so having a treatment like this in the armory will be absolutely critical to prevent deaths.”

As part of this initiative, Pfizer has agreed to not receive royalties from the sale of its drug by the generic companies while the coronavirus pandemic remains classified as a global health emergency by the World Health Organization.

In addition, Pfizer will continue this policy for sales to low-income countries while lower-middle-income countries and upper-middle-income countries will be subject to a 5% royalty for sales to the public sector and a 10% royalty for sales to the private sector.

Despite both Pfizer and Merck both struck deals with MPP to allow generic COVID-19 drug in some parts of the world, no companies have currently licensed their vaccine to the MPP.

Licensed Drugs Explained

Paxlovid is a treatment for those afflicted with mild to moderate SARS-CoV-2 infection as long as they are 12 or older and above 88 pounds. The drug is approved for Emergency use by the FDA and is composed of two drugs (Nirmatrelvir and Ritonavir) working together. Nirmatrelvir [PF-07321332] is a SARS-CoV-2 main protease (Mpro) inhibitor (also known as SARS-CoV2 3CL protease inhibitor) that works by inhibiting viral replication in the early stages of the disease to prevent progression to severe COVID-19. To go along with this effect Ritonavir is used for much the same purpose that it is in HIV treatment. It is co-administered with nirmatrelvir to help slow the body’s metabolism so that nirmatrelivr can remain active in the body for longer periods of time at higher concentrations to help combat the virus.

On Merck’s side of things, there is the drug molnupiravir that is meant to combat the virus by inducing mutations. Molnupiravir is a prodrug of beta-D-N4-hydroxycytidine (NHC), a ribonucleoside that has broad antiviral activity against RNA viruses.  This drug is provided in pill form and is under emergency use authorization and is under some concerns of possibly inducing mutations in humans. 

Implications of the Generic Drug

Besides the obvious benefit to global health and equitable access, this generic drug project will help billions of people speed along with their recoveries and help many countries deal with the struggles of this already trying economic situation. The creation of generic drugs for a fair price and in satisfactory quantity is important even outside of a pandemic goes doubly so for an airborne contagion.

Author

Eduardo Longoria